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. 2017 Dec 21:13:52.
doi: 10.1186/s13223-017-0224-7. eCollection 2017.

Feasibility of sustained response through long-term dosing in food allergy immunotherapy

Sandra Andorf #  1 , Monali Manohar #  1 , Tina Dominguez  1 , Whitney Block  1 , Dana Tupa  1 , Rohun A Kshirsagar  1 , Vanitha Sampath  1 , R Sharon Chinthrajah #  1 , Kari C Nadeau #  1
Affiliations

Feasibility of sustained response through long-term dosing in food allergy immunotherapy

Sandra Andorf et al. Allergy Asthma Clin Immunol. .

Abstract

Background: Clinical trials using oral immunotherapy (OIT) for the treatment of food allergies have shown promising results. We previously demonstrated the feasibility of desensitization for up to 5 food allergens simultaneously through OIT. In this observational study, we report the findings of long-term follow-up (LTFU) of the participants treated through a single site OIT phase 1 trial.

Methods: The participants (n = 46) were followed up to 72 months since the time they reached 2 g maintenance dose per food in the initial phase 1 trial. During the long-term maintenance dosing, participants continued or reduced the initial maintenance dose of food allergen protein to high (median 2 g protein) vs. low (median 300 mg protein). Participant follow-up included clinical monitoring, standardized OFCs, and in some cases, skin prick tests and measurement of allergen-specific IgE and IgG4.

Results: Irrespective of the high vs. low long-term maintenance dose during LTFU, all participants were able to ingest 2 g protein of each food allergen protein during OFCs performed at the end of our LTFU.

Conclusion: Our LTFU cohort of food OIT participants from a single site, phase 1 OIT study, supports the feasibility of sustained desensitization through long-term maintenance dosing. Trial registration Registry: Clinicaltrial.gov. Registration numbers: NCT01490177 (original study); NCT03234764 (LTFU study). Date of registration: November 29, 2011 (original study); July 26, 2017 (LTFU study, registered).

Keywords: Desensitization; Food allergy; Maintenance; Oral immunotherapy.

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Figures

Fig. 1
Fig. 1
Long-term maintenance doses at the end of LTFU: high vs. low long-term maintenance dose at the end of the follow-up study per participant for each of their respective offending foods administered as a part of OIT is depicted
Fig. 2
Fig. 2
Kaplan–Meier curves of participants on a high maintenance dose over time stratified by allergen: The percentage of participants per allergen continuing a high long-term maintenance dose over time is shown. Black censor lines indicate the time point, where the participants on a high dose were at the conclusion of our follow-up study
Fig. 3
Fig. 3
SPT wheal diameters over time: SPT wheal diameters per allergen per participant in the context of time since the maintenance dose of 2 g was reached in the original phase 1 study. Each line represents one participant
Fig. 4
Fig. 4
IgG4/IgE ratios over time: IgG4/IgE ratios per allergen per participant in the context of time since the maintenance dose of 2 g was reached in the original phase 1 study. Each line represents one participant
Fig. 5
Fig. 5
Timeline of high vs. low maintenance doses per participant per allergen: The time of for which each participant was on a high (gray horizontal line) or a low (orange horizontal line) maintenance dose is shown grouped by respective offending foods administered through OIT. The time points of OFCs and the respective outcome are shown as tick marks
See this image and copyright information in PMC

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